Skip to main content

Table 2 Comparison of clinical and biochemical variables at baseline and at the end of the study in the different arms (per protocol analysis)

From: Policaptil Gel Retard® significantly reduces body mass index and hyperinsulinism and may decrease the risk of type 2 diabetes mellitus (T2DM) in obese children and adolescents with family history of obesity and T2DM

  Arm A Arm B Arm C
  T 0 T 1 T 0 T 1 T 0 T 1
BMI (SDS) 2.32 ± 0.53 1.80 ± 0.36*** 2.23 ± 0.57 1.99 ± 0.56*° 2.27 ± 0.74 2.18 ± 0.70°°°
Acanthosis nigricans, n (%) 7 (13.2) 3 (5.6)** 6 (13.3) 6 (13.3) 4 (11.4) 4 (11.4)
IGT 6 (11.3) 4 (7.5) 5 (11.1) 4 (8.8) 4 (11.4) 3 (8.6)
T2DM 2 (3.8) 1 (1.9) 1 (2.2) 1 (2.2) - -
Fasting glucose, mg/dL 90.62 ± 4.32 84.02 ± 4.23*** 89.63 ± 3.17 86.72 ± 6.00§§§°°° 90.90 ± 5.71 90.12 ± 2.89°°°
Fasting insulin, μU/mL 27.60 ± 7.83 18.04 ± 3.44*** 26.71 ± 9.36 22.09 ± 3.67**°°°§§§ 27.39 ± 8.61 25.91 ± 4.41°°°
HbA1c, %, mmol/mol 5.63 ± 0.54 5.37 ± 0.35** 5.70 ± 0.52 5.40 ± 0.51* 5.68 ± 0.58 5.54 ± 0.50
HOMA-IR, mean (range) 5.69 (3.60–9.92) 3.38 (2.64–5.38)*** 5.68 (2.00–10.90) 4.90 (3.15–6.26)*°°°§§§ 5.78 (4.21–8.89) 5.76 (4.00–6.19)°°°
ISOGTT, SDS 1.40 ± 0.24 3.16 ± 0.83*** 1.42 ± 0.22 1.74 ± 0.40***°°° 1.56 ± 0.48 1.43 ± 0.21°°°
Insulinogenic index, mean (range) 3.66 (1.90–9.25) 2.79 (1.84–8.27)* 2.54 (1.91–10.2)## 2.40 (0.82–5.87) 3.12 (1.15–9.70) 2.95 (1.22–6.78)
Disposition index, mean (range) 4.42 (2.25–11.97) 10.28 (5.36–21.65)*** 4.01 (0.83–11.72) 4.93 (1.53–7.27)*°°° 3.79 (1.88–9.28) 3.84 (1.69–5.82)°°°
Total cholesterol (mmol/L) 4.39 ± 0.51 3.31 ± 0.59*** 4.36 ± 1.09 3.58 ± 0.93** 4.51 ± 0.79 3.74 ± 0.86**°
LDL cholesterol (mmol/L) 3.05 ± 0.60 2.87 ± 0.67 2.96 ± 0.73 2.92 ± 0.78 3.12 ± 0.81 2.99 ± 0.87
Triglycerides (mmol/L) 1.54 ± 0.40 1.63 ± 0.45 1.48 ± 0.29 1.61 ± 0.43 1.62 ± 0.51 1.54 ± 0.58
  1. BMI, body mass index; BP, blood pressure; HOMA-IR, homeostasis model of assessment for insulin-resistance; ISOGTT, Matsuda index; SDS, standard deviation score; IGT, impaired glucose tolerance; T2DM, type 2 diabetes mellitus. Cross-sectional study: Arm A vs. Arm B or Arm A vs. Arm C: ##p < 0.005. Longitudinal study: Arm A vs. Arm A. Arm B vs. Arm B, Arm C vs. Arm C: *p<0.05, **p<0.005, ***p < 0.0005; Arm A vs. Arm B or Arm A vs. Arm C: °p < 0.05, °°°p < 0.0005; Arm B vs. Arm C: §§§p < 0.0005.